Bayer, J&J win second U.S. trial over Xarelto bleeding risks

(Reuters) - A federal jury has cleared Bayer AG and Johnson & Johnson of liability in the second trial to stem from thousands of lawsuits blaming injuries on the blood thinner Xarelto, the drug companies said on Monday.

The logo of Bayer AG is pictured at the Bayer Healthcare subgroup production plant in Wuppertal, Germany February 24, 2014. REUTERS/Ina Fassbender/File Photo

The verdict by a jury in New Orleans came in a lawsuit by the husband and children of Sharyn Orr, who blamed her 2015 death following a stroke on inadequate information the companies provided her doctor about the drug’s bleeding risks.

The case is second in a series of bellwether trials in the federal product liability litigation over Xarelto’s bleeding risks. The companies also won in a previous trial on May 3.

The two cases are among an estimated 18,600 lawsuits in federal and state courts related to Xarelto. Bellwethers are supposed to help both sides assess similar claims that the companies downplayed the drug’s bleeding risks.

Bayer in a statement said the two verdicts “affirm both the safety and efficacy of Xarelto, and that its FDA-approved label contains accurate, science-based information on the benefits and risks of this life-saving medicine.”

J&J’s Janssen Pharmaceuticals Inc unit in a statement said it will continue to defend against the allegations in the litigation.

Andy Birchfield and Brian Barr, co-lead counsel for the plaintiffs, in a statement said they “will continue to press forward with the legal claims of the thousands of innocent victims of this drug.”

The U.S. Food and Drug Administration approved Xarelto in 2011. The drug is prescribed for people with a common heart rhythm disorder known as atrial fibrillation and to treat and reduce the risk of deep vein thrombosis and pulmonary embolisms.

But plaintiffs contend Xarelto was unreasonably dangerous and that J&J and Bayer, which jointly developed it, failed to warn patients about a serious risk of uncontrollable, irreversible bleeding in emergencies.

In the trial over Orr’s death, her husband, Joseph Orr, and her surviving children said she suffered a stroke in late April 2015, a year after her doctor prescribed her Xarelto to treat her atrial fibrillation.

The plaintiffs’ lawyers said that based on inadequate information from Bayer and J&J, a doctor decided to wait 12 hours before operating because he feared the Xarelto she took would cause Orr to bleed out. She died on May 4, 2015, despite the surgery.

Bayer and J&J contended Xarelto’s warnings were adequate and that any purported inadequacy did not cause her death.

The case is In Re Xarelto Products Liability Litigation, U.S. District Court, Eastern District of Louisiana, No. 14-md-2592.

Reporting by Nate Raymond in Boston; Editing by Dan Grebler and Lisa Shumaker